AlcoholNCT06903143
Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia
A study testing Screening, brief intervention, and referral to treatment (SBIRT) in people with Alcohol, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Alcohol
- What is being tested?
- Screening, brief intervention, and referral to treatment (SBIRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteZambia
- Study dates
- 1 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-24 years of age
- Residing in Lusaka, Zambia
- Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).
Who cannot join
- Unable or unwilling to provide informed assent/consent
Trial locations and contacts
1 site in 1 country.
About this study
This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:
Specific aims:
- Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).
- Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.
- Conditions
- Alcohol
- Being tested
- Screening, brief intervention, and referral to treatment (SBIRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, brief intervention, and referral to treatment (SBIRT)Behavioural
The intervention will consist of a 30 minute alcohol brief intervention based on CETA' substance use reduction element; if warranted, referral will be made for the full CETA intervention, which consists of 6-12 weekly cognitive behavioral therapy-based sessions.
| Study group | Role | What they receive |
|---|---|---|
| Screening, brief intervention, referral to treatment (SBIRT) | Experimental | Sixty AYA will be recruited from three existing HIV prevention and treatment service settings in Lusaka. These are settings where our team has both previous and current successful research studies and are real-world settings where AYA are currently receiving services. The study will be introduced to AYA during morning 'health talks' held at outpatient and ART departments as well as to AYA accessing youth friendly spaces in the three sites. Interested AYA can choose to meet with an on-site research assistant (RA). The RA will obtain informed consent and administer a brief demographics questionnaire. The RA will then conduct an alcohol screening as it would be done in the SBIRT program: the administration of the AUDIT-C screener (a 3-question brief version of the full AUDIT) and will then ask the AYA to provide a urine sample in a private bathroom. The RA will then use an EtG dipcard and after ten minutes record whether the test is positive/negative for recent alcohol consumption. The A Receives: Behavioral: Screening, brief intervention, and referral to treatment (SBIRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Measured: Baseline, 3-month follow-up
Secondary outcomes (1)
Ethyl glucuronide rapid dip stick
EtG urine dipstick test provides positive/negative result for any alcohol use in past 2-3 days
Measured: Baseline, 3-month follow=up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Sep 2025
- Primary completion1 Mar 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903143
- Sponsor's protocol ID
- AAAV3113
- Status last verified
- Jul 2026
- First submitted
- 24 Mar 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia
- ClinicalTrials.gov ID
- NCT06903143
- Acronym / sponsor ID
- AAAV3113
- Conditions
- Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:
Specific aims:
- Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).
- Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening, brief intervention, referral to treatment (SBIRT) | Experimental | Behavioral: Screening, brief intervention, and referral to treatment (SBIRT)Sixty AYA will be recruited from three existing HIV prevention and treatment service settings in Lusaka. These are settings where our team has both previous and current successful research studies and are real-world settings where AYA are currently receiving services. The study will be introduced to AYA during morning 'health talks' held at outpatient and ART departments as well as to AYA accessing youth friendly spaces in the three sites. Interested AYA can choose to meet with an on-site research assistant (RA). The RA will obtain informed consent and administer a brief demographics questionnaire. The RA will then conduct an alcohol screening as it would be done in the SBIRT program: the administration of the AUDIT-C screener (a 3-question brief version of the full AUDIT) and will then ask the AYA to provide a urine sample in a private bathroom. The RA will then use an EtG dipcard and after ten minutes record whether the test is positive/negative for recent alcohol consumption. The A |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 16-24 years of age
- Residing in Lusaka, Zambia
- Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed assent/consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening, brief intervention, and referral to treatment (SBIRT)The intervention will consist of a 30 minute alcohol brief intervention based on CETA' substance use reduction element; if warranted, referral will be made for the full CETA intervention, which consists of 6-12 weekly cognitive behavioral therapy-based sessions. | Behavioural | Screening, brief intervention, referral to treatment (SBIRT) |
Primary outcome
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
Time frame: Baseline, 3-month follow-up
1 secondary outcome
Ethyl glucuronide rapid dip stick
Time frame: Baseline, 3-month follow=up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, brief intervention, and referral to treatment (SBIRT) in people with Alcohol, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) (time frame: Baseline, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.